A Study To Demonstrate The Bioequivalence Of Rosiglitazone XR (BRL-049653) 8mgs XR Manufactured At Two Different Sites.

Phase 1

Completed

• Conditions: Alzheimer's Disease
• Interventions: Drug: RSG XR

• Registration Number: NCT00468897
• Lead Sponsor: GlaxoSmithKline

Brief Summary

The present pharmacokinetic study is designed to compare bioavailability and assess bioequivalence of two Rosiglitazone XR formulations produced at two different sites.Both formulations will be tested in fasting healthy volunteers

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03-21
• Study First Submitted: 2007-05-01
• Study First Submitted QC: 2007-05-01
• Primary Completion: 2007-05-02
• Study Completion: 2007-05-02
• Study First Posted: 2007-05-03
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-03
• Last Update Posted: 2017-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Healthy male or female aged 18-55 years.
• BMI between 19 - 30 kg/m2

Exclusion criteria:

• Liver function tests above the upper limit
• Excessive alcohol consumption history
• History of Cigarette smoking
• Positive HIV, Hep B or C test
• Positive pregnancy test
• History of heparin sensitivity
• History of glucose intolerance

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment Arm BA	RSG XR	A will be a single tablet RSG XR 8 mg manufactured in Harlow administered in the fasted state and B will be a single tablet RSG XR 8 mg manufactured in Crawley administered in the fasted state. In Arm BA subject will receive B regimen in Period 1 and A regimen in Period 2. There will be wash-out period of 5 days between doses.
Treatment Arm AB	RSG XR	A will be a single tablet RSG XR 8 milligram (mg) manufactured in Harlow administered in the fasted state and B will be a single tablet RSG XR 8 mg manufactured in Crawley administered in the fasted state. In Arm AB subject will receive A regimen in Period 1 and B regimen in Period 2.There will be wash-out period of 5 days between doses.

Primary Outcome Measures

Name	Time	Method
PK samples	at Pre-dose,0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32

Secondary Outcome Measures

Name	Time	Method
Safety and tolerability as measured by adverse events, vital signs clinical laboratory measurements.	Up to 32

Trial Locations

Locations (1)

GSK Investigational Site; 🇩🇪 Neuss, Nordrhein-Westfalen, Germany